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Clinical Trials/NCT06306651
NCT06306651
Recruiting
N/A

Comparative Study Between High Flow Nasal Cannula and Conventional Oxygen Therapy in the Postoperative Management of Patients With Mild to Moderate Obstructive Sleep Apnea

Ain Shams University1 site in 1 country60 target enrollmentMarch 16, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
High Flow Nasal Cannula
Sponsor
Ain Shams University
Enrollment
60
Locations
1
Primary Endpoint
Oxygen desaturation index
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

This study aims to compare the effectiveness of conventional oxygen therapy oxygen and high-flow nasal cannula therapy on oxygen saturation (SpO2), measuring number of SpO2 drop >4% of base line oxygen saturation (o2 desaturation index), length of the ICU stay, and the need of use supplemental continuous positive airway pressure (CPAP) support in any of the study groups in the postoperative ICU setting.

Detailed Description

In the surgical setting, patients with obstructive sleep apnea (OSA) may have increased upper airway collapsibility affecting ventilation and increased sensitivity to sedation from anesthetics and opioids. Surgical patients with OSA have a high risk for postoperative complications, including cardiac events, hypoxemia, and transfer to the intensive care unit . Continuous positive airway pressure (CPAP) is the gold standard treatment for moderate to severe OSA , and effectively reduces the risk of cardiovascular events. Evidence has shown that CPAP effectively reduces length of ICU stay (LOS) in the postoperative setting. In these scenarios, conventional oxygen therapy and high-flow nasal cannula (HFNC) therapy have been used as an alternative for CPAP non-adherent patients. HFNC delivers warm, humidified air through a nasal cannula at high flow rates of up to 60 L/min. This high flow rate may increase end-expiratory pharyngeal pressure up to 3 cm H2O, decreasing the force required to alleviate airway collapse . Using a nasal cannula interface in contrast to the CPAP mask may provide a more comfortable experience for patients during sleep .

Registry
clinicaltrials.gov
Start Date
March 16, 2024
End Date
March 1, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Omar medhat

Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Ain Shams University, Cairo, Egypt.

Ain Shams University

Eligibility Criteria

Inclusion Criteria

  • Age group from 21 - 40 years old.
  • Both sexes.
  • Mild to moderate obstructive sleep apnea (OSA) patients with STOP-BANG score less than
  • OSA patients undergoing non cardiac surgeries.
  • Patients who will undergo scheduled elective surgeries under general anesthesia.

Exclusion Criteria

  • Patient refusal of procedure or participation in the study.
  • Patients with severe OSA, STOP-BANG score more than or equal
  • Patients dependent on home ventilation CPAP or bilevel devices.
  • Pregnant females.
  • Post cardiac or thoracic surgery patients.
  • More than American Society of Anesthesiologists (ASA) II patients.
  • Head and face trauma patients.

Outcomes

Primary Outcomes

Oxygen desaturation index

Time Frame: During intensive care unit stay (assessed up to day 5)

Oxygen desaturation index will be recorded through by pulse oximeter, while respiratory rate will be recorded by the ECG monitoring and visual count hourly. The number of recorded drops in baseline SpO2 of \>4%.

Secondary Outcomes

  • The incidence of ventilatory support(At the time of intensive care unit discharge (up to day 5))
  • The length of Intensive care unit stay(At the time of intensive care unit discharge (up to day 5))

Study Sites (1)

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